52 Week Trial of Liraglutide in Type 1 Diabetes

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

Moreover, the potential impact of a glucagon-like peptide-1 agonist on measures of abdominal fat (assessed by CT scan), insulin sensitivity (assessed by the gold standard euglycemic-hyperinsulinemic clamp) and satiety sensations have not been evaluated in this population.

It had two arms (groups): Liraglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Participants will be submitted to this double-blind cross-over protocol of 52-week use of liraglutide/placebo.

Who Took Part

The registry lists 15 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2013-04 with completion listed for 2015-04.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Assessment of Changes in Glycemic Control by HbA1c (time frame: Measure changes in HbA1c at 24 and 52 weeks from baseline).

It also tracked 1 secondary outcome, for example Assessment of Changes on Adipose Tissue.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 15 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.